Apotex is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines (both generic and innovative pharmaceuticals) for patients around the world. We are the 7th largest generic pharmaceutical company globally with more than 12,000 employees and estimated sales of approximately $3 billion. Our fully integrated operation is comprised of four lines of business: Global Generics; Apobiologix; Global Active Pharmaceutical Ingredients (API); and ApoPharma (Innovative Products). With our worldwide manufacturing sites, Apotex can produce up to 24 billion dosages per year. We produce 300 medicines in 4,000 dosages and formats that are exported to 115 countries. Apotex will spend $2 billion over the next 10 years on research and development.

 

Job Summary

With consultation with Scientific leader, Analytical Development, responsible for performing all activities in early development research, analytical method development and validation for new products, comprehensive testing of API and finished dosages, and generates regulatory submission documentation.  Acts as a key member in the project working team. Provides technical support to validation, technical transfer and submission as required.

 

Job Responsibilities

Key Job Responsibilities

  • Prepares working plan for new projects and provides timeline to the project working team.
  • Develops stability indicative analytical methods for drug substance and drug product as well as the procedures used to determine the residue on manufacturing equipment.
  • Prepares draft methods and method validation protocols.
  • Performs validation of analytical testing procedure for drug substance and drug product including dissolution methods.
  • Evaluates the stability and determines physicochemical properties of the drug substance.
  • Evaluates the stability performance of the trial formulations under forced degradation conditions with comparison of the reference product.
  • Performs isolation and purification of degradation products.
  • Prepares stability reports for forced degradation, proposes degradation pathway and provides recommended storage condition for drug products.
  • Provides justification for specification limit of degradation products based on ICH guideline, stability data and compendia requirements.
  • Performs releasing tests for bio batches and initial tests for stability batches.  Conducts other tests required for dosage submissions.
  • Documents and reports results as per established SOP’s.
  • Provides technical support to other department for the issues related to the stability of drug substance and drug product or for the responses to requirements of regulatory agencies.
  • Work as a member of a team to achieve all outcomes.
  • Performs additional related duties, as assigned, in accordance with job responsibilities and necessary departmental objectives.
  • Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence; Demonstrates strong and visible support of our values.
  • Performs all work in accordance with all established regulatory and compliance and safety requirements.
Job Requirements
  • Recognized post secondary education in analytical chemistry, organic chemistry, pharmaceutical sciences, or related field.
  • BSc with 5 years or MSc with 3 years or PhD with 0-1 years experience in a pharmaceutical lab in an R&D environment.
  • Knowledge of HPLC method development and method validation.
  • Knowledge of wet chemistry, analytical bench techniques, Window-based software, and automated data acquisition systems.
  • Working knowledge of GC is an asset.
  • Good written and verbal English communication skills.

 

 

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.
 
Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

 

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About Apotex

Apotex Inc. was founded in 1974, and is the largest Canadian-owned pharmaceutical company. From its 2 employees, 5,000 square foot beginning, the company has grown to employ over 6,500 people in research, development, manufacturing and distribution facilities world-wide. The Canadian operations of the Apotex Group of Companies with 5,800 employees now occupy over 3 million square feet in Montreal, Richmond Hill, Toronto, Etobicoke, Mississauga, Brantford, Windsor, Winnipeg, London, Calgary and Vancouver. Apotex produces more than 300 generic pharmaceuticals in approximately 4,000 dosages and formats which, in Canada, are used to fill over 89 million prescriptions a year – the largest amount of any pharmaceutical company in this country.

Today, Apotex is a necessary and trusted member of Canada’s healthcare community. The company’s pharmaceuticals can be found in virtually every pharmacy and healthcare facility in Canada and are exported to over 115 countries around the globe. Export markets represent an ever growing portion of the total sales. Apotex has also established a presence through subsidiaries, joint ventures or licensing agreements in Australia, Belgium, Czech Republic, Mexico, Netherlands, New Zealand, Poland, Turkey, and the in, to name just a few. Healthcare professionals around the world rely on Apotex for quality and value.

Although the company’s own business is developing and manufacturing generic pharmaceuticals, the success of Apotex has enabled it to diversify into a number of other health-related areas. The Apotex Pharmaceutical Group of Companies also researches, develops, manufactures and distributes fine chemicals, non-prescription and private label medicines, and disposable plastics for medical use.

The worldwide sales of the Apotex Group of companies exceed $1 billion (Canadian $) per year.